| NEWS
news R
ECENTLY UNVEILED DATA from a multi-centre, randomised, double-blind trial that showed 20 U of Vistabel (Allergan; onabotulinumtoxin type A) was as effective as 30 U of
Xeomin /Bocouture (Merz Aesthetics; incobotulinumtoxinA) for the treatment of moderate to severe glabellar lines. The study results were presented during the 7th European Masters in Anti-Aging Medicine (EMAA) congress in Paris. 'This new study underlines why it is
important that medical aesthetic practitioners are aware of the differences between each of the botulinum toxins when selecting the most appropriate treatment for their patients,' commented Dr Moers-Carpi from Munich, Germany, and lead investigator for the study. 'With botulinum toxin manufacturers each having unique definitions of a Unit, aesthetic practitioners should be vigilant in adopting the treatment protocol set by the respective manufacturer and not translating previous experience with one toxin to another.'
The British Association of Aesthetic Plastic Surgeons (BAAPS) has expressed concern that clinics replacing faulty PIP implants claim 'not
to have the skills' to treat
problems stemming from rupture. Patients are instead being sent to the NHS to undergo further surgery separately. The BAAPS asserts that any trained and qualified plastic surgeon would be able to efficiently address the repercussions of rupture, and warns the initiatives could simply be a cost-containment exercise.
A round-up of news stories in the aesthetic and anti-ageing medicine industry
Study reinforces need for awareness of the different doses for botulinum toxin type A The objective of the study was to evaluate
the efficacy of Vistabel in the treatment of moderate to severe glabellar lines, when compared with Bocouture. Response was measured as a 1 point or greater improvement in the Facial Wrinkle Scale (FWS). The primary endpoint was the proportion of responders at day 28.
Secondary
endpoints included injector and patient assessment of the severity of glabellar lines at maximum contraction, based on the FWS at days 84, 98 and 112. In the trial, 224 patients with
moderate or severe glabellar lines were randomised to receive a single treatment cycle of either Vistabel (20 U) or Bocouture (30 U). At day 28, the number of responders in the Vistabel treatment group was 108 (96%), compared to 106 responders (95%) treated with Bocouture. The response rate for the two
treatment groups was statistically equivalent, demonstrating that 20 Units of Vistabel is as effective as 30 Units of Bocouture at the end of 4 weeks. Patient-reported assessments of response using the FWS confirmed the injector findings throughout the 16 weeks of the study, with comparative benefit observed with both treatments. 'Allergan has an extensive
and deep understanding of the science behind botulinum toxins based on more than 21 years of research and development. As with all biological products, no two manufacturered botulinum toxin products are the same,' said
Dr Antony Fulford-Smith, VP and Head of Medical Affairs at Allergan in Europe, Africa and the Middle East. 'We are pleased to see further evidence for the efficacy of VISTABEL and consider that this study provides further clarity that Vistabel and the Merz unit doses are not interchangeable in clinical practice.'
CLINICS 'DO NOT HAVE SKILLS' TO TREAT IMPLANT VICTIMS According to consultant plastic
surgeon and BAAPS President, Fazel Fatah:
'One of the side-effects from
ruptured PIP implants is an inflammatory response in the tissues exposed to the silicone — which is known to be of industrial, rather than medical grade. This can manifest as lumps and bumps in the chest area, under the breast, and enlarged lymph nodes. The lumps that form around the breast — a reaction to free silicone known as
granulomas — can vary in size and if large, may require it to be surgically removed. The lymph glands, which are located in the armpits, act as a filter mechanism and they can become affected
and engorged. If greatly
enlarged or becomes painful they may require removal after investigation. 'Any qualified plastic surgeon
can easily address these issues, make the appropriate decisions and manage arrangements for investigation in an effective
BTX-A DOSING NOT INTERCHANGEABLE
manner — it is part of standard training. Although it may be ostensibly reassuring that untrained practitioners aren’t just trying to ‘have a go’ at complex procedures, these actions then beg the question: who are the surgeons performing the implant replacements and what training have they undergone? Otherwise, one may be pardoned for assuming that this initiative is purely a cost-containment exercise. The alternative doesn’t thinking of.'
bear
prime-journal.com | March 2012 ❚ 9
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